(156 days)
Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:
- Separate tissue or structures compromised by surgical trauma
- Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity
- Help control minimal bleeding following surgery or trauma
- Help control minimal bleeding following surgery or nasal trauma by tamponade effect blood absorption and platelet aggregation
- Act as an adjunct to aid in the natural healing process
Indicated for use as a nasal hemostat to treat epistaxis.
Intended for use under the direction of a licensed healthcare provider.
Intranasal splints are utilized to stop nasal hemorrhage and for the prevention of tissue adhesion in the nasal and/or sinus cavities. It is often used after FESS, nasal/sinus surgery, or surgical trauma in the event of excessive epistaxis. Splints are gently inserted into the nasal cavity. The device is designed to swell within the nasal cavity in order to exert pressure on the bleeding sites.
The splint material is dissolvable. Splints can also be used following sinus surgery in order to hold cartilage and membranes in their proper places during healing following surgerv.
The Chitosan Intranasal Splint is made from Carboxymethyl Chitosan, mixed with Methyl Cellulose, and Hydroxyethyl Cellulose to make an absorbent porous sponge that is flexible and dissolvable. The device acts as a nasal splint and temporary spacer.
The provided text describes a 510(k) premarket notification for a medical device called "ChitoZolve," an intranasal splint. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, specifically concerning an AI/ML-driven device.
The document focuses on demonstrating that ChitoZolve is substantially equivalent to a predicate device (Hemostasis PosiSep / PosiSep X). The performance testing described is for the physical and biological characteristics of the splint itself, such as:
- Reconstitution (volume)
- Expansion (dimensional height)
- Dissolution time (In vitro)
- Platelet adhesion, whole blood coagulation
- Firmness
- Pliability
- Thickness
- pH
- Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity)
- Stability/Shelf life
It explicitly states: "No animal or clinical testing was conducted. The use of the device type has been documented in published literature and indicates safe and effective use for the target procedures and expected patient populations."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device, a sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the non-AI/ML device described in the document.
The document is a regulatory submission for a physical medical device and not an AI/ML diagnostic or therapeutic system.
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.